FDA 510(k) Application Details - K090300

Device Classification Name Pump, Infusion, Elastomeric

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510(K) Number K090300
Device Name Pump, Infusion, Elastomeric
Applicant ACE MEDICAL US, LLC
9102 TURFWAY BEND DR.
POWELL, OH 43065 US
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Contact ANDREW LAMBORNE
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Regulation Number 880.5725

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Classification Product Code MEB
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Date Received 02/06/2009
Decision Date 04/30/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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